HRP20120701T1 - Human monoclonal antibodies to fucosyl-gm1 and methods for using anti-fucosyl-gm1 - Google Patents

Human monoclonal antibodies to fucosyl-gm1 and methods for using anti-fucosyl-gm1 Download PDF

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Publication number
HRP20120701T1
HRP20120701T1 HRP20120701TT HRP20120701T HRP20120701T1 HR P20120701 T1 HRP20120701 T1 HR P20120701T1 HR P20120701T T HRP20120701T T HR P20120701TT HR P20120701 T HRP20120701 T HR P20120701T HR P20120701 T1 HRP20120701 T1 HR P20120701T1
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Croatia
Prior art keywords
antibody
antigen
variable region
chain variable
binding portion
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HRP20120701TT
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Croatian (hr)
Inventor
Cynthia A. Vistica
Eric H. Holmes
Peter Brams
Alison Witte
Josephine M. Cardarelli
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Medarex, Inc.
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Publication of HRP20120701T1 publication Critical patent/HRP20120701T1/en

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3076—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties
    • C07K16/3084—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties against tumour-associated gangliosides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/77—Internalization into the cell

Claims (19)

1. Izolirano humano monoklonsko protutijelo, ili njegov dio koji veže antigen, koje obuhvaća varijabilnu regiju teškog lanca koja sadrži domene CDR1, CDR2, i CDR3; i varijabilnu regiju lakog lanca koja sadrži domene CDR1, CDR2, i CDR3, gdje: (a) varijabilna regija teškog lanca CDR1 obuhvaća SEQ ID NO: 16; (b) varijabilna regija teškog lanca CDR2 obuhvaća SEQ ID NO:22; (c) varijabilna regija teškog lanca CDR3 obuhvaća SEQ ID NO:28; (d) varijabilna regija lakog lanca CDR1 obuhvaća SEQ ID NO:34; (e) varijabilna regija lakog lanca CDR2 obuhvaća SEQ ID NO:40; i (f) varijabilna regija lakog lanca CDR3 obuhvaća SEQ ID NO:46, pri čemu se protutijelo specifično veže za Fukozil-GM1.1. An isolated human monoclonal antibody, or antigen-binding portion thereof, comprising a heavy chain variable region comprising CDR1, CDR2, and CDR3 domains; and a light chain variable region comprising the CDR1, CDR2, and CDR3 domains, wherein: (a) the heavy chain variable region CDR1 comprises SEQ ID NO: 16; (b) the heavy chain variable region CDR2 comprises SEQ ID NO:22; (c) the heavy chain variable region CDR3 comprises SEQ ID NO:28; (d) light chain variable region CDR1 comprises SEQ ID NO:34; (e) light chain variable region CDR2 comprises SEQ ID NO:40; and (f) light chain variable region CDR3 comprises SEQ ID NO:46, whereby the antibody specifically binds to Fukozil-GM1. 2. Protutijelo prema zahtjevu 1, pri čemu se protutijelo veže za staničnu liniju DMS-79 humanog raka malih stanica pluća (Human SCLC ATCC # CRL-2049).2. The antibody of claim 1, wherein the antibody binds to the human small cell lung cancer cell line DMS-79 (Human SCLC ATCC # CRL-2049). 3. Protutijelo ili njegov dio koji veže antigen prema zahtjevu 1 ili 2, koje obuhvaća varijabilnu regiju teškog lanca koja je barem 95% identična sekvenci aminokiselina SEQ ID NO:61; i/ili varijabilnu regiju lakog lanca koja je barem 95% identična sekvenci aminokiselina SEQ ID NO:62.3. Antibody or antigen-binding portion thereof according to claim 1 or 2, comprising a heavy chain variable region that is at least 95% identical to the amino acid sequence of SEQ ID NO:61; and/or a light chain variable region that is at least 95% identical to the amino acid sequence of SEQ ID NO:62. 4. Protutijelo ili njegov dio koji veže antigen prema bilo kojem od zahtjeva 1 do 3, gdje: (a) varijabilna regija teškog lanca obuhvaća sekvencu aminokiselina SEQ ID NO:4; i (b) varijabilna regija lakog lanca obuhvaća sekvencu aminokiselina SEQ ID NO:10.4. The antibody or antigen-binding part thereof according to any of claims 1 to 3, where: (a) the heavy chain variable region comprises the amino acid sequence of SEQ ID NO:4; and (b) the light chain variable region comprises the amino acid sequence of SEQ ID NO:10. 5. Izolirano humano monoklonsko protutijelo, ili njegov dio koji veže antigen, gdje se protutijelo unakrsno natječe za vezanje za Fukozil-GM1 s referentnim protutijelom, pri čemu je referentno protutijelo izolirano humano monoklonsko protutijelo kako je definirano u bilo kojem od zahtjeva 1 do 4.5. An isolated human monoclonal antibody, or an antigen-binding portion thereof, wherein the antibody cross-competes for binding to Fukozil-GM1 with a reference antibody, wherein the reference antibody is an isolated human monoclonal antibody as defined in any of claims 1 to 4. 6. Protutijelo prema bilo kojem od zahtjeva 1 do 5, a koje je protutijelo pune duljine izotipa IgG1 ili IgG4.6. The antibody according to any one of claims 1 to 5, which is a full-length antibody of the IgG1 or IgG4 isotype. 7. Protutijelo ili njegov dio koji veže antigen prema bilo kojem od zahtjeva 1 do 5, koje je Fab ili Fab’2 fragment ili jednolančano protutijelo.7. The antibody or antigen-binding part thereof according to any one of claims 1 to 5, which is a Fab or Fab'2 fragment or a single-chain antibody. 8. Protutijelo ili njegov dio koji veže antigen prema bilo kojem od zahtjeva 1 do 5, gdje je to protutijelo hipofukozilirano protutijelo.8. The antibody or antigen-binding portion thereof according to any one of claims 1 to 5, wherein the antibody is a hypofucosylated antibody. 9. Smjesa koja sadrži protutijelo ili njegov dio koji veže antigen prema bilo kojem od zahtjeva 1 do 8 i farmaceutski prihvatljivi nosač.9. A mixture containing an antibody or an antigen-binding part thereof according to any one of claims 1 to 8 and a pharmaceutically acceptable carrier. 10. Imunokonjugat koji sadrži protutijelo ili njegov dio koji veže antigen prema bilo kojem od zahtjeva 1 do 8 koji je vezan za terapijsko sredstvo kao što je citotoksin ili radioaktivni izotop.10. An immunoconjugate comprising an antibody or antigen-binding portion thereof according to any one of claims 1 to 8 which is linked to a therapeutic agent such as a cytotoxin or a radioactive isotope. 11. Smjesa koja sadrži imunokonjugat prema zahtjevu 10 i farmaceutski prihvatljivi nosač.11. A mixture containing an immunoconjugate according to claim 10 and a pharmaceutically acceptable carrier. 12. Molekula izolirane nukleinske kiseline koja kodira protutijelo ili njegov dio koji veže antigen prema bilo kojem od zahtjeva 1 do 8.12. An isolated nucleic acid molecule encoding an antibody or an antigen-binding portion thereof according to any one of claims 1 to 8. 13. Vektor ekspresije koji sadrži molekulu nukleinske kiseline prema zahtjevu 12.13. An expression vector containing a nucleic acid molecule according to claim 12. 14. Stanica domaćin koja sadrži vektor ekspresije prema zahtjevu 13.14. A host cell containing an expression vector according to claim 13. 15. Postupak pripreme anti-Fukozil-GM1 protutijela koji obuhvaća ekspresiju protutijela u stanici domaćinu prema zahtjevu 14 te izoliranje protutijela iz stanice domaćina. 15. The procedure for the preparation of anti-Fucosyl-GM1 antibodies, which includes the expression of the antibody in the host cell according to claim 14 and the isolation of the antibody from the host cell. 16. Protutijelo ili njegov dio koji veže antigen prema bilo kojem zahtjevu 1 do 8, za uporabu u liječenju bolesti naznačene rastom tumorskih stanica koje eksprimiraju Fukozil-GM1.16. The antibody or antigen-binding portion thereof according to any of claims 1 to 8, for use in the treatment of a disease characterized by the growth of tumor cells expressing Fukozil-GM1. 17. Protutijelo ili njegov dio koji veže antigen za uporabu prema zahtjevu 16, pri čemu je bolest rak.17. The antibody or antigen-binding portion thereof for use according to claim 16, wherein the disease is cancer. 18. Protutijelo ili njegov dio koji veže antigen za uporabu prema zahtjevu 17, gdje rak je rak pluća.18. The antibody or antigen-binding portion thereof for use according to claim 17, wherein the cancer is lung cancer. 19. Protutijelo ili njegov dio koji veže antigen za uporabu prema zahtjevu 18, gdje rak pluća je rak malih stanica pluća.19. The antibody or antigen-binding portion thereof for use according to claim 18, wherein the lung cancer is small cell lung cancer.
HRP20120701TT 2005-12-08 2012-09-04 Human monoclonal antibodies to fucosyl-gm1 and methods for using anti-fucosyl-gm1 HRP20120701T1 (en)

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US74891505P 2005-12-08 2005-12-08
PCT/US2006/061817 WO2007067992A2 (en) 2005-12-08 2006-12-08 Human monoclonal antibodies to fucosyl-gm1 and methods for using anti-fucosyl-gm1

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EP (1) EP1960434B1 (en)
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